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When the challenge results for the first RSV antiviral were announced the stock quickly tanked and most of the publicity called the trial a failure. I agree that the market value is at all time lows, but I am cautious because selling ENTA for year end tax losses indicates that there is not much belief that any of those "free shots" are going to pan-out in the near future, i.e., there is a belief that there is plenty of time to make purchases of ENTA after first profiting form other near term purchases.
I bought on the positive news of the first RSV challenge study, I already had an accumulation of shares going back as far as 2015; I was baffled when all of the negative responses to the challenge study were vocalized.
That is my sad, sad story. I continue to have a lot of hope for Enanta, but my new expectations are that I have spent enough money, I am still faithful to my belief that the company is quite valuable far beyond my average cost, and I accept that any new investments for me are likely better spent on other equities which have demonstrated better trends in response to positive news.
Merry, Merry,
Sinking-and-Stinking-On-Positive-News
I have been buying
Not hard to add as it is trading so much below cash value with multiple free shots to much higher valuation.
"ENTA with a nice jump today on no news,"
And today it got hit - again with no news. Looks like tax selling is not over yet. Only 6 more trading days.
Interesting. Word is getting out.
https://twitter.com/factcatpoll/status/1736081974991741217
Thanks Dew and DC15 for the heads up and the link. EDP-323 is now up at bat with a study completion date in mid 2024. I assume we will hear about the new drug candidates ENTA is working on before that.
This is the trial listing:
https://clinicaltrials.gov/study/NCT06170242
The RSV Challenge study has posted to CT.gov. It indicates that the first subject has enrolled, this does not necessarily mean that the first subject has been treated, and it would not matter because the study is double blinded so we wouldn't know if the subject got the drug or placebo.
ENTA with a nice jump today on no news, well except that the FED isn't going to raise interest rates. The volume isn't very heavy so I hope this isn't just another head fake with a drop tomorrow. It would be nice to see a follow up in the rest of December, perhaps as part of a much mentioned Santa Claus rally.
With the SGEN buyout being finalized tomorrow I will have a nice chunk of cash to invest. I will put a bit more money into ENTA, RVNC and EXEL. The latter is in my view a good take over target but it will be nice to see a follow up in the rest of December. Also wondering if the PFE downturn is overkill.
Anyone adding? Or all waiting for tax selling to end?
From the latest webcast, it seems like they might have more than one new focus area coming up next year. I thought it would be just one
I like the idea, but I think it's more likely that the situation is more similar to Enanta's; it's harder now to show differentiation in a weaker form of the virus and with the current aggregate of people with natural immunity and/or vaccine derived immunity.
As to the effect of the lawsuit, IF the Enanta case shows merit and Pfizer has to pay Enanta some amount of money it could finance a possible self funded third phase trial of EDP-235, which could impact sales of Paxlovid or impact further sales of ANY covid antivirals. Following that thought, it could also explain reluctance to partner with Enanta to develop EDP-235 in phase 3 trials (what if Pfizer wins the suit?)
It's a separate question as to whether Enanta's or Pfizer's new compound is best. We may never know.
Likewise if Pfizer doesn't develop their new compound we won't know about that outcome.
As with a swine flu or avian flu they often just go away, and resurface again.
Yet COVID (they say) will always be with us and there remains a possibility that a more threatening form will resurface- and when it does it may again reappear in groups that have lost the natural and vaccine derived immunity. Higher lethality?
It's possible either COVID antivirus could be on hold until such a time that its more fiscally sound to continue trials. Some bean counter with have to decide that OR a re-emergence of a more lethal form may make it a no-brainer.
I'm just sitting on the sidelines waiting and hoping. : )
Wonder if it’s anything related to the ongoing litigation?
Still no news about Pfizer's second generation Covid 19 drug. The primary completion date for the phase 2 trial was Sept 13 2023 and the actual completion date was Oct 11th.
https://clinicaltrials.gov/study/NCT05799495?term=PF-07817883&rank=5
https://clinicaltrials.gov/study/NCT05799495?term=PF-07817883&rank=5
Enanta: Multiple Shots On Goal For RSV Makes This A Must Watch
Nov. 30, 2023 3:34 PM ETEnanta Pharmaceuticals, Inc. (ENTA)PFE
Terry Chrisomalis profile picture
Terry Chrisomalis
Investing Group Leader
Summary
Two mid-stage studies RSVHR and RSVPEDs are being advanced using EDP-938 for RSV; data from at least one of these studies expected Q3 of 2024.
Data to be released from phase 2a challenge study, using L-protein inhibitor EDP-323, expected in Q3 of 2024.
It is expected that the global Respiratory Syncytial Virus market is expected to reach $4.20 billion by 2027.
The company has enough cash to fund its operations until fiscal 2027 and has the option to raise additional funds through a mixed shelf offering.
ENTA’s pro forma net cash @9/30/23=$200.6M—treating ENTA’s deferred-royalty obligations as debt (as is done under GAAP [#msg-172603887]—but see note at bottom of this post). The $200.6M figure, which is down $20.6M relative to 6/30/23, consists of:
• $360.0M net current assets on the 9/30/22 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/0001177648/000095017023065884/enta-20230930.htm#consolidated_balance_sheets );
• ($159.4M) deferred long-term liabilities on the 9/30/23 balance sheet relating to the OMERS royalty agreement. ($35.1M of liabilities relating to the OMERS agreement are booked as current liabilities and hence are included in the $360.0M figure in the first bulleted item.)
Note: Excluding the “debt” associated with the OMERS royalty agreement, ENTA’s pro forma net cash at 9/30/23 was $394.1M ($200.6M + $159.4M + $35.1M).
ENTA’s fully-diluted share count @9/30/23=26.0M—a decrease of 0.1M since 6/30/23.
The 26.0M figure above consists of: 21.06 basic shares on the 9/30/23 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/0001177648/000095017023065884/enta-20230930.htm#consolidated_balance_sheets ); and 4.94M options and unvested restricted-stock shares and equivalents (whether or not exercisable) (ibid, page F-13).
must be tough for Luly, his 800k shares used to worth around 70 millions at peak.. now it's 7 millions. And he is 65 years old? I would think he would love an exit.
Good for them all the other options are way out of the money at the moment
Somebody did management a favor today, deliberately or not, insofar as newly issued stock options granted to ENTA’s executive officers were priced at today’s close.
That's correct. Today’s S-3 filing supersedes the S-3ASR filing from 8/9/21 (https://www.sec.gov/Archives/edgar/data/1177648/000156459021042633/enta-s3asr.htm ). For technical reasons, ENTA is no longer able to use an S-3ASR registration, but an S-3 works essentially the same way.
Notably, the $100M ATM with Jefferies, which was tied to the 8/9/21 shelf registration and was never tapped, is now defunct.
It looks like this is just a replacement for the 2021 shelf
https://ir.enanta.com/node/12286/html
Almost every small bio keeps an active shelf as a matter of course
Not going to sell any at 11 or 9. The company has potential to worth much more - and with potential buyout, settlement, partnership, upcoming
With the cash (~15and royalty steam - it has next to zero downside risk in term of terminal value.
This 200M is a special kind of debt bc of the virtually guaranteed coverage from the royalty stream. If the fund who “loaned “ the 200M doesn’t want to assume the “debt” of enta goes belly up any number of suitors would take on the debt for the royalty in whole or at 90 cents on the dollar in a heartbeat.
So in this case the lowering f shareholder value because of this accounting maneuver is not as relevant as it normally would be IMO
Good for you in timing your sale. Happy thxgiving
One of the things from your summary of the quarter that is missing is the annual decrease in shareholder equity - down to $216,735K from $321,334K last year. With the decreased expenses projected next year, the reduction should be less, but if the loss from operations is still $80M, instead of $133M, net worth might be ~$135M after 09/24.
I still think net worth is much more important than cash to analyze financial health. The "debt" has to be paid back. It will be paid (out of the future cash flow), just like any kind of other borrowing.
I took yesterday's rally as an opportunity to sell 1/2 my position (obviously should have sold all). Other people's tax selling may hold down the price for the next 5-6 weeks.
The move yesterday didn't make much sense, the move today doesn't either - it ends up as a wash as the traders have fun with this
I do think the rationale for trading below cash has to be mitigated bc of the low burn, which will further decrease substantially as the phase 2s wrap up. At that point ENTA will still have way more cash than the current market cap, and either good data to then ramp up to phase 3, partner, etc. (and they can then monetize the remainer of the royalty and have more cash in one years time than they have now even), or the data is a dud and spending drops to a crawl with no clinical drugs to progress. It also appears the lawsuit will be at a critical juncture by then too
so between now and 9-12 months from now the traders can have their fun
I find it a stretch to think preclinical candidates to be announced early next year can move things much but you never know every now and then you can get excitement for a very early stage drug but that is unusual (e.g. BMY paying 800M for a preclinical IDO)
I remember a time of great discontent upon any declaration of information which was readily accessible from the day's chart, alas there is recognition that recapitulation of the otherwise obvious can help one to persevere.
Welcome to table.
Easy come, easy go as ENTA gives back most of yesterday’s gains.
Given the buildup in anticipation Jay Luly has created for the announcement of ENTA's new therapeutic areas in January, I doubt that MASLD (f/k/a NAFLD) fits the bill since it's an area ENTA has previously worked in.
Infringement lawsuit, more dates from PacerMonitor website 11/21
Judge Denise J. Casper: ELECTRONIC ORDER entered granting133 Motion to Modify Scheduling Order. Fact discovery to be completed by 12/22/23. Expert disclosures by the party with the burden of proof by 2/9/24. Rebuttal expert disclosures by 3/29/24. Expert discovery to be completed by 4/30/24. Summary Judgment and Daubert Motions to be filed by 5/28/24. Opposition to Summary Judgment and Daubert Motions to be filed by 6/18/24. Reply briefs by leave of court. Hearing on Motions for Summary Judgment and Daubert Motions set for 7/31/24 at 2:00PM. If no summary judgment motions are filed, hearing will be converted to an initial pretrial conference. The parties shall confer regarding the topics identified under Local Rule 16.5(d) and shall prepare and submit a joint pretrial memorandum in accordance with Local Rule 16.5(d) no later than five (5) business days prior to the pretrial conference. The pretrial memorandum shall also propose deadlines for the filing of motions in limine, proposed jury instructions, proposed voir dire and a proposed trial date. In light of this new schedule, the status conference set for 12/4/23 is canceled. (Hourihan, Lisa)
MASLD, just my guess. On Oct 27 I cryptically posted "Embracing MASLD" upon stumbling onto a tie to the change in naming convention and an Enanta employee. There are also year 2022 and year 2023 enanta patent applications US and world wide for molecules relating to inhibitors of metabolic diseases. I am not certain the GLP-1 specifically is the target.
Obviously Luly and ENTA know more about running a company than I do. I suggested the possibility of ENTA funding EDP-235 phase 3 Covid trials if a partner wasn't found as a signal of their faith in EDP-235. Instead, Luly and ENTA reduced research expenses to prolong the cash runway until 2027, which propelled the stock price higher today. Being wrong never felt so good. :). Kudos to dewophile for stain he was pleased that cash burn has been reduced.
I was pleased to hear that ENTA referenced their patent infringement lawsuit against PFE. Winning that lawsuit would be major price driver for ENTA.
Oral GLP-1 is a crowded arena (#msg-173206117), but it can't be completely ruled out.
Correction—The references to "calendar 3Q23" for the data readout of ENTA's RSV trials should be "calendar 3Q24." (h/t vinmantoo)
Thanks for catching that typo!
Any chance it would be GPL 1?
ENTA reports FY4Q23* results and pipeline update:
https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-reports-financial-results-its-fiscal-37
FY4Q23 royalty revenue was $18.9M, unchanged from the prior quarter. 54.5% of ENTA’s Mavyret royalties are payable to OMERS†, and this amount is treated for accounting purposes as an amortization of debt (see discussion in #msg-172603887).
9/30/23 cash = $370M, a decrease of $23M relative to 6/30/23.
Today, ENTA issued FY2024* guidance as follows:
• R&D expense of $100-120M, down sharply from $163.5M in FY2023.
• SG&A expense of $45-50M, down modestly from $52M in FY2023.
Based on the reduced operating expenses described above, ENTA says its cash and expected royalty revenue are sufficient to fund operations for the next four years—i.e. through the end of FY2027.
Pipeline
• EDP-938 (RSV N-protein inhibitor): ENTA expects to report data from the phase-2b RSVPEDs (pediatric) and the phase-2b RSVHR (high-risk adults) trials in calendar 3Q23, assuming there is a normal RSV season in the Northern Hemisphere.
• EDP-323 (RSV L-protein inhibitor): ENTA just started a phase-2a “challenge” study; data expected in calendar 3Q23.
• The preclinical program for single-agent dual inhibition of RSV and hMPV has been terminated.
• EDP-235 (COVID protease inhibitor): If a partnership is secured for a phase-3 trial, the population tested will be standard-risk patients with a primary endpoint based on symptom relief.
• Non-virology: “The company will announce new therapeutic programs beginning in early 2024.” An analyst on today’s CC asked if one of these programs was GLP-1, but ENTA declined to answer.
*ENTA’s fiscal years end on September 30
†Ontario Municipal Employees Retirements System (Canada’s largest pension fund)
>> clarity on Covid regulatory pathway
Well, we get some clarify on this... high risk is no go as hospitalization rate is low, standard risk will be the way to go.
Only one question for 285. (and it's the last question) so I guess it means the covid curse will be ending soon.
And market can shift focus on its cash, RSV candidates and royalty steam.
Will be interesting to see what's the new area they are targeting.
I don’t think the timing is right to monetize the remainder of the royalty. They don’t have enough in NOLs to offset the tax
I don’t think they should fund Covid unless there is some new data showing why they would change course
>> would it be a good move for them to fund the Covid phase 3 trials themself?
Hope not. Not after they committed couple times to only proceed with a partner.
That would tell everyone nobody actually wants its covid drug but themselves.
Monday. The best news we can hope for:
- partnership on either Covid or RSV
- seeking strategy alternatives including sale of the company
- clarity on Covid regulatory pathway
- sold the remaining royalties for around 200mm
- share buyback
By the way, New 13G filed on this name.
The market jumped so much this morning that even ENTA is up. Will wonders never cease!
Good time to get in...added this morning for $9.10
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